Effect of Chronic Exposure to Nextida GC-B on Glycemic Control in Adults With Normoglycemia or Pr… (NCT07149064) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Chronic Exposure to Nextida GC-B on Glycemic Control in Adults With Normoglycemia or Prediabetes
Canada60 participantsStarted 2026-02-18
Plain-language summary
The goal of this clinical trial is to investigate the safety and efficacy of Nextida GC-B on glycemic control in adults with normoglycemia and prediabetes. The main question it aims to answer is:
What is the difference in change in postprandial glycemic control from baseline at Day 90 between Nextida GC-B and placebo as assessed by glucose incremental AUC (iAUC 0-180 min).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females 18 years and older
. BMI of 25 to 34.9 kg/m2, inclusive
. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
. Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
. Double-barrier method
. Intrauterine devices
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The difference in change in postprandial glycemic control between Nextida GC-B and placebo
Timeframe: Day 0 to 90
2
The difference in change in glycated hemoglobin (HbA1c) and glucose variability from baseline at Day 90 between Nextida GC-B and placebo
. Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
. Vasectomy of partner at least 6 months prior to screening
Exclusion criteria
. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product, placebo or standardized meal ingredients
. Metal implants or other physical characteristics/limitations that may affect DEXA scan results as assessed by the QI
. Poor venous access as assessed by the QI
. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3)
. Unstable metabolic disease or chronic diseases as assessed by the QI
. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI